Job Responsibilities

• Maintains appropriate quality oversight of SOPs for manufacturing and operational activities.
• Reviews records to ensure compliance with ISO 9001 requirements per written procedures (e.g. manufacturing critical logbooks, batch records, clinical data, changeover records).
• Maintains hard copy and electronic control documents and records.
• Manages file maintenance program for all documented information, including intellectual properties from customers and/or external providers.
• Performs documentation management and distribution; record reconciliation, keeping and filing of all controlled documentation.
• Ensures all documents are up-to-date.
• Keeps other personnel updated on new document versions and how to obtain access.
• Controlled prints and distributes documents as needed.
• Retrieves documents and records as needed.
• Ensures all documents and files are clearly labelled and indexed and that this information is consistent with the naming and numbering system.
• Ensures all information is readable with no deterioration and legibility issues.
• Handles records across various departments to prevent loss of integrity and improper use.
• Establishes record retention timelines and maintains records to the defined timelines.
• Performs periodic review of archived documents and records based on retention timelines.
• Handles records disposition after retention period.
• Identifies and resolves document control related issues.
• Deviations/Customer Complaints - Participates in investigations, reviews investigation reports; Trends and reports quality systems related information (deviations, investigations, change controls, CAPAs, related tasks etc).
• Undertakes tasks assigned by leaders as and when appropriate.

Requirements

• Certificate, Diploma or Advanced Diploma in Chemical Engineering, Pharmaceutical Science or relevant discipline. GCE ‘A’ levels school leavers are welcome to apply and will be considered for an entry level position.
• Minimum 2 years of work experience in ISO 9001, ISO 13485 or GxP document and/or records management or similar work environment would be an advantage.
• Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
• Experience with electronic DMS, ERP, MES (Electronic Batch Records) would be an advantage.
• Familiar and keeping up to date with current and applicable GxP regulations and standards; experience with regulatory requirements such as Singapore/HSA, US/FDA, EU/EMEA etc. would be an advantage.
• Able to work independently, self-starter, self-motivated and task oriented as well as a strong team player.
• Fast learner and with a “can-do” attitude.
• Good communication skills, diplomatic and able to openly communicate and escalate any relevant issues.
• During the start-up phase of the facility, be willing to take on expanded role to set up the team and workflow/processes as needed.